Research & Development News

Collaboration focused on Phase 2II clinical trial to evaluate use of Allergan's Cenicriviroc and Novartis' lead FXR agonist to treat NASH.

Additional clinical data are needed to determine the most appropriate doses.

Two separate agreements with Biogen and Roche.

The company's small molecule drug program is aimed at treating cancer and autoimmune diseases .

Study to evaluate potential of APX005M plus Opdivo to activate antigen-presenting cells in the tumour micro-environment to demonstrate enhanced anti-tumour activity.

Drug discovery software specialists combine expertise to extend studies into drug metabolism modelling.

Results showed that people treated with Alecensa lived significantly longer without their disease progressing compared to crizotinib when given as initial (first-line) treatment.

 “Synthetic biomarkers” could be used to diagnose ovarian cancer months earlier than now possible.

Botox is currently being studied as a potential treatment option for adult patients with moderate to severe MDD.

CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR.

ECF843 is a new therapeutic approach and potential first-in-class Rx treatment in dry-eye.

Phase I clinical study of KITE-585 in patients with multiple myeloma planned for 2017.

Applications include data from the largest international trial conducted in multiple myeloma.

New indication of Tafinlar and Mekinist in advanced NSCLC provides only therapy approved in the EU for BRAF V600-positive NSCLC.

Companies to initiate Phase III registrational trials in first-line NSCLC across the spectrum of PD-L1 expression and first-line head and neck cancer in 2017.

New production method for solid dispersions of docetaxel and paclitaxel.

Unique mechanism: glutamate modulation and voltage-gated sodium channel blockade.

French Health Authority ANSM grants approval in the Mutual Recognition Procedure; the relevant health authorities are required to implement the new indication within 30 days.

Trumenba has been studied in a global clinical development program evaluating the vaccine in adolescents and adults.

Patients studied in the trial were reflective of those undergoing catheter ablation in routine clinical practice, providing highly relevant data to treating physicians.

Landmark real-world evidence from an international study of more than 300,000 patients with type-2 diabetes showed treatment with SGLT-2 inhibitors reduced risk of hospitalization for heart failure by 39% and all-cause mortality by 51%.

Agonists for GIT, CD27 and CD40 receptors in development for cancer immunotherapy exhibit significant in vitro- and in vivo activities.

New use of insulin was also reduced by 29% among patients taking Entresto compared to enalapril-treated patients.

Team led by Dr David Brough awarded £191,757 by public-private initiative driving early-stage drug discovery programmes.

Amgen has announced that the 27,564-patient Repatha (evolocumab) cardiovascular outcomes study, FOURIER, established for the first time that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible wit...

Kisqali plus letrozole showed treatment benefit across all patient subgroups regardless of disease burden or tumour location.

Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin

Supports small molecule ion channel drug discovery, from initial screening to development candidate.

Alliance brings together eye care and CRISPR innovators to develop transformative medicines for patients.

Data suggest an alternative option for patients.

BI 836858 was previously granted orphan drug designation for the treatment of patients with AML.

Work on a second-generation fusion protein due to start in 2017 at Patheon's manufacturing facility in Brisbane.

Collaboration is the second to evaluate a combination of CV301 with a checkpoint inhibitor.

Partnership formed to evaluate the impact of Amplycell’s novel cell fitness technology on expression capacity of Horizon’s bioproduction cell line.

Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.

Cosentyx has shown superior and sustained results versus both Stelara and Enbrel, delivering long-lasting clear or almost clear skin.

Vertex to develop CTP-656 for potential use in future combination regimens aimed at treating the underlying cause of CF.

Provides hope for patients with severe asthma, who currently have very limited treatment options.

Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

MEDI8897 has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season.

More patients now able to receive a standard-of-care treatment with Erbitux plus Folfiri or Folfox.

Affinivax’s MAPS vaccine technology overcomes the limitations of current conjugate vaccine technology, creating a MAPS pneumococcal vaccine that enables broader protection.

Second Biologics License Application accepted by the FDA for avelumab.

If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment.

Compared with warfarin, Pradaxa was associated with a 26% reduced risk of stroke and a 20% reduced risk of major bleeding.

Tool explores the time course of drug exposure, biomarker response and outcome.

Antibody levels maintained against multiple targets 6 months post vaccination.

Experimental vaccine targets mosquito saliva.

Aids R&D initiatives to advance precision medicine.

Modified baker’s yeasts cause an immune response and the production of lymphocyte killers, which detect and eliminate cancerous cells.

New kit enables covalent conjugation of antibodies and proteins to magnetic particles.

Trial data further supports the existing clinical profile of CT-P13 in inflammatory bowel disease.

Study showed that people whose disease expressed PD-L1 and were treated with Tecentriq plus Avastin had a 36% reduction in the risk of their disease worsening

Steroid-free Spiriva Respimat now approved as asthma treatment for age 6 and older.

More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year.

Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU.

The presentations highlight Alzheon’s ‘precision medicine’ approach to drug development for Alzheimer’s disease.

If approved, this treatment could be the first two-drug regimen for HIV.

Foresee technology can help to develop stable, formulated peptides in solution for controlled-release therapy for 3- and 6-month durations of action after a single injection.

NIH-funded research suggests zebrafish models may be efficient resource for identifying drugs for clinical use.

JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor.

Boehringer Ingelheim to conduct trial in collaboration with a subsidiary of Merck (MSD).

NIH-funded preclinical study suggests a possible treatment for Alzheimer’s disease and other neurodegenerative disorders.

By the end of 2017, company plans to increase to 230 process chemists and 70 analytical chemists.

Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint.

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

Opdivo has now been approved in six tumour types in just over 2 years.

First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.

Decision marks the third TSC-related indication for Votubia in the EU.

New clinical data for Avycaz demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens.

Amgen receives positive CHMP opinion for biosimilar adalimumab.

Actelion R&D unit to spin out into standalone company based and listed in Switzerland.

Combination studied as treatment for patients with advanced clear cell renal cell carcinoma.

AnestaGel uses a novel approach to delivering sustained-released analgesics into the target tissue via the Matrix, which is a tunable, biocompatible, and pH neutral platform.

Clinical trial is the first of its kind to treat IBS symptoms by cannabinoid-containing chewing gum.

Disease prevalence can be monitored with a precision never before possible.

Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates.

VR647 is a drug/device combination, using the AKITA JET smart nebuliser, for the delivery of nebulised budesonide.

Feasibility study to examine three different oral formulations engineered with Enteris’ Peptelligence platform.

Extends multi-year agreement in drug discovery with focus on cardiovascular and central nervous system disorders, immunology, infectious diseases and oncology.

The molecule, which is a PPMO, will likely be ready for testing in humans in about 3 years.

Topline results from the Phase II trial are expected by year-end 2017.

Sofosbuvir/Velpatasvir/Voxilaprevir cranted an accelerated assessment by the EMA.

Once-daily treatment reduces persistent facial erythema associated with rosacea through 12 hours.

Opdivo demonstrated a 37% reduction in the risk of death compared to placebo.

Therapies targeted at this novel mechanism have the potential for disease-modification because they will address the genetic root cause of AD.

Opiorphin represents a new class of potent and safe painkiller.

leon nanodrugs' MJR technology offers reformulation options that address API solubility issues.

WHF therapy can be directly applied on a wound to stimulate the natural human wound healing process.

All programs (two promising clinical-stage programs targeting DNA damage and repair, and two novel pre-clinical programs) have first-in-class and best-in-class potential.

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation.

New study to evaluate combination of Lartruvo and Keytruda.

KumaMax could provide hope celiac patients who try, but are unable to completely avoid gluten exposure in their diets,

JOTROL is being developed to remedy resveratrol’s poor bioavailability and dose limiting gastrointestinal side effects.

Phase Ib/II studies to explore a novel immuno-oncology combination in hematological and solid tumours with high unmet medical need.

Noxxon continues transition to clinical oncology company.

The company's long-acting therapeutic peptides are designed to allow the efficient delivery of the active element to intracellular targets.

Resunab is designed to resolve inflammation thus having the potential to provide significant clinical benefit to CF patients, importantly without immunosuppression.

Reported research continues to demonstrate the anti-cancer properties of cannabinoids.

The participating NIPTE team will primarily focus on biopharmaceutical formulations and product development, and FDA regulatory science.

Study is exploring potential benefits of combining a cancer vaccine and PD-1 checkpoint inhibitor.

Ocrevus is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies.

New FDA-approved indications for Adynovate provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.

Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events.

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

Computationally intelligent drug discovery platform receives two Fierce Innovation awards for Biotech Innovation and Best New Product.

Spinraza improved motor function in SMA patients.

Development and licence agreement is for pMDI inhaled triple therapy (VR2076) for asthma and COPD.

Abdominal pain improved 56% with CR1 300 mcg relative to placebo in Phase IIb trial.

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

First and only PARP inhibitor in the US indicated t.o treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations.

Ionis earns $25 million milestone payment.

AB-SA01 meets primary endpoints of safety and tolerability and reduces S. aureus bacterial load in all patients.

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

The project aims to create a step-change in the capabilities of current bioproduction methods, meeting unmet needs in the field of viral vector production.

Catalent Biologics will employ its proprietary GPEx cell line technology and ambr workstation to develop, optimize the process for expression, and manufacture antibodies for further investigation by MVI and its partners.

Phase IV study demonstrates a lack of improvement in progression-free survival in patients with chemotherapy-naïve metastatic CRPC whose prostate-specific antigen has previously progressed on Xtandi.

New shareholder, Axxamof Milan, Italy, will transfer certain therapeutic assets to the R&D programs of Acousia.

"MEDI1814 has a unique mechanism among antibodies in clinical development and could provide a distinct approach to treating Alzheimer's disease."

Collaboration will explore the potential of novel applications of Albumedix’s albumin-based drug delivery platform, Veltis.